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Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac A... | Recruiting
Randomised Controlled Trial to Asse... | Recruiting
Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients
BYPASS-CTCA

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Medical Conditions
  • Ischaemic Heart Disease
  • Contrast-induced Nephropathy
Primary Contact Details
Recruitment Status
Recruiting
Trial source and source ID number
NCT03736018
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive coronary angiography. Invasive coronary procedures in patients with bypass grafts can be more complicated due to the variation in bypass graft ostia. This can lead to longer procedure times, with higher doses of contrast and radiation and more discomfort for the patient. The aim of this study is to see if the use of computed tomography cardiac angiography (CTCA) in patients with previous bypass grafts prior to invasive coronary angiography will help make their procedure safer and quicker.
Research Details
  • The BYPASS-CTCA trial is a single-centre, randomised controlled trial, which plans to recruit 688 patients who have had previous bypass grafts and require invasive coronary angiography over a period of 30 months.

    Patients will be randomised to receive either computed tomography cardiac angiography (CTCA) prior to their invasive coronary angiogram, or invasive coronary angiography alone.

    The primary endpoints will be the incidence of contrast induced nephropathy, the duration of the invasive coronary angiographic procedure and patient satisfaction. A number of secondary endpoints will also be looked at.

    Findings from BYPASS-CTCA will potentially demonstrate that a CTCA prior to invasive coronary angiography in this cohort of patients reduces the incidence of contrast-induced kidney injury, the length of procedure and improves patients satisfaction. The results of this trial may influence future clinical practice guidelines in coronary artery bypass graft patients undergoing invasive coronary procedures.
Phase
N/A
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Diagnostic Test : CTCA

Study Arm Groups : CTCA + ICA

Intervention Type
See Interventions above
Primary Outcome Measures
    Procedural duration; From time of arterial sheath insertion to removal of arterial catheters; Incidence of Contrast Induced Nephropathy; 48-72hours; Patient satisfaction; 4-6hours
Secondary Outcome Measures
    Contrast amount; From time of arterial sheath insertion to removal of arterial catheters; Radiation exposure; From time of arterial sheath insertion to removal of arterial catheters; Angiography related complications; 4-6hours; Radial access rate; From time of randomisation to end of invasive coronary angiogram procedure; Catheters used; From time of arterial sheath insertion to removal of arterial catheters; Computed Tomography Cardiac Angiography accuracy; From time of randomisation to end of invasive coronary angiogram procedure; Number of grafts not identified; From time of arterial sheath insertion to removal of arterial catheters; Cost effectiveness of computed tomography cardiac angiography; 12 months
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
688
Participant Inclusion Criteria
    Inclusion Criteria:

    1. Patients undergoing invasive coronary angiogram +/- percutaneous coronary Intervention

    2. Previous Coronary Artery Bypass Grafting (CABG)

    3. Aged ≥18

    4. Patients able and willing to give their written informed consent.

    Exclusion Criteria:

    1. Subjects presenting with ST elevation myocardial infarction, cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation.

    2. Subjects with eGFR <20ml/min or on renal replacement therapy.

    3. Current life-threatening condition other than vascular disease that may prevent a subject completing the study.

    4. Clinical instability including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.

    5. Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease or asthma, complete heart block, second-degree atrioventricular block

    6. Known contrast dye allergy.

    7. Pregnancy or unknown pregnancy status.

    8. Patients considered unsuitable to participate by the research team (e.g., due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures).

    9. Inability or refusal to provide informed consent.

    10. Any inclusion criteria not met
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
London
Trial Contact(s)
Primary Trial Contact
Anne-Marie Beirne, MRCP BSc
02037658707
Other Trial Contacts
Mervyn Andiapen
02037658707
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised Controlled Trial Assessing the Value of Computed Tomography Cardiac Angiography in Improving Patient Satisfaction and Reducing Contrast Load, Procedural Duration and Complications in Patients Who Had Previous Bypass Operation Undergoing Invasive Coronary Angiography
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
Reda 012466
Sponsor(s)
Queen Mary University of London
Key Dates

Recruitment Start Date

Nov 2018

Recruitment End Date

May 2021

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

05 Nov 2018

Date updated in source

14 Jan 2019